confidential: for review only · 2017-09-07 · antimicrobial usage (amu): two main issues are...

Confidential: For Review O

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Antimicrobials policy interventions in the food animal

production in the Southeast Asia region

Journal: BMJ

Manuscript ID BMJ.2016.035858

Article Type: Analysis

BMJ Journal: BMJ

Date Submitted by the Author: 30-Sep-2016

Complete List of Authors: goutard, flavie luce; CIRAD, Department ES, UPR AGIRs; Kasetsart University Faculty of Veterinary Medicine, Bordier, Marion; CIRAD, Department ES, UPR AGIRs Calba, Clémentine; CIRAD, Department ES, UPR AGIRs Erlacher-Vindel, Elisabeth; World Organisation for Animal Health (OIE) Góchez, Delfy; World Organisation for Animal Health (OIE) de Balogh, Katinka; Food and Agriculture Organization of the United Nations, Regional Office for Asia and the Pacific Benigno, Carolyn; Food and Agriculture Organization of the United Nations, Regional Office for Asia and the Pacific Kalpravidh, Wantanee; Food and Agriculture Organization of the United Nations, Regional Office for Asia and the Pacific Roger, Francois; CIRAD, Department ES, UPR AGIRs; Kasetsart University Faculty of Veterinary Medicine, Vong, Sirenda; World Health Organization REgional Office for South-East Asia, Health Security and Emergency Response

Keywords:

https://mc.manuscriptcentral.com/bmj

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Antimicrobials policy interventions in the food animal production in the Southeast Asia

region

Flavie Goutard and colleagues call for concerted multi-sectoral measures through stronger policies to combat antimicrobial resistance. Flavie Luce Goutard1,2* senior epidemiologist

Marion Bordier1 PhD candidate

Clémentine Calba1 research assistant

Elisabeth Erlacher-Vindel3 Head , Science and New Technologies Department

Delfy Góchez3 Chargée de mission

Katinka de Balogh4 Senior officer

Carolyn Benigno4 Antimicrobial projects coordinator

Wantanee Kalpravidh4Regional manager

Francois Roger1,2 director

Sirenda Vong5 regional technical lead, Antimicrobial resistance.

1. CIRAD, UPR AGIRs, F-34398 Montpellier, France 2. Kasetsart University, 10900 Bangkok, Thailand 3. World Organisation for Animal Health (OIE), Paris, France 4. Food and Agriculture Organization of the United Nations, Regional Office for Asia and the Pacific, Bangkok, Thailand 5. World Health Organization, Regional Office for South-East Asia, New Delhi, India Guarantor*: [email protected]

Introduction

Antibiotics have been widely used in food animal production to treat sick animals, contain disease spread,

prevent bacterial contamination of the food chain, and increase production [1]. However, their misuse and

overuse in humans and animals leads to the emergence of antimicrobial resistance (AMR) [2]. In September

2016, the United Nations recognized the global rise of AMR as a threat to global health and human

development [3]. Recent projections estimated that by 2050 ~10 million people will die of AMR annually

worldwide if the current situation goes unchecked [4] ; the annual global gross domestic product would fall

by 1.1-3.8% with a major impact on global poverty; and the decline in global livestock production could

range from 3% to 8% per year [5]. Of national animal health systems evaluated in approximately 130

countries by the World Organisation for Animal Health (OIE) including Veterinary Services through its PVS

Pathway, more than 110 do not yet have appropriate legislations to regulate importation, manufacture,

distribution and use of antimicrobials agents. Consequently, antibiotics circulate uncontrolled like common

goods and are often falsified [6]. Furthermore, Van Boeckel et al. (2015) estimated that the antimicrobial

consumption for livestock would increase by 67% by 2030, to face growing demand for meat products in

middle-income countries [7]. This pattern is all the more true in a rapid growing economic area like the

World Health Organization (WHO) South-East Asia region (SEAR: Bangladesh, Bhutan, Democratic

People's Republic of Korea (DPRK), India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand,

Timor-Leste). With several countries as global farming and food industry exporters of meat and aquaculture

products [8], the region has embarked into intensive farming systems involving rising consumption of

fertilizers, antibiotics, and pesticides for which many farmers have limited technical knowledge. The

lack/weakness of regulation, adequate policy, and standards implementation for antibiotic usage in livestock

sector associated with low standards of hygiene and sanitation accelerate AMR emergence and dissemination

[2]. SEAR is thought to be the epicenter of AMR [9].

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We determined challenges and needs regarding policy interventions to combat AMR in food animal

production in the SEAR with a focus on antimicrobial development/marketing, usage and resistances

monitoring. We reviewed official documents addressing antibiotics in food animal production in each SEAR

countries.

Evidences

We followed the PRISMA requirements [10] to conduct our literature review, using PubMed, Science Direct,

MEDLINE, LISTA, Web of Science and Scopus for the peer-reviewed publications; and Google Scholar for

the gray literature (see figure 1). We focused our search on English-speaking articles with available abstracts

published during 2010- April 2016. Our review, which complied with PRISMA requirements, used

additional search strategies (searches in the FAO legislative and policy database (Faolex) available at

http://faolex.fao.org/ and contacts with OIE national focal points for Veterinary Products and FAO contacts).

From the documents, we extracted information about: (i) drugs and medicine development and marketing,

(ii) drugs and medicine usage, and (iii) AMR surveillance and monitoring. For each record retrieved, we

captured data related to the competent authority in charge, the type of document (policy or legal document),

the objective(s), the key components and limitations. These results were crossed-checked with additional

information regarding policy implementation and law enforcement found in the other non official documents

[2,11–13].

Type of policy or legal documents available from the literature review – (see Table 1)

A total of 91 documents met the search criteria, of which 26 were official records addressing antimicrobial

development/marketing, usage, and resistances monitoring. Of these, 16 are legal instruments while 10 are

policies, related strategies, and action plans. Policy documents are usually more recent and up-to-date

regarding AMR issues than legal instruments, showing that the appropriate legal framework is not yet in

place to allow governments to implement the course of actions defined in their policy. Most topics in the

documents cover drug and medicine development and marketing (15/26), drug and medicine usage (15/26)

while few (5/26) address consumption and resistance monitoring/surveillance.

Country-specific analysis of policies, legislations and regulations – Gaps identification (see Table 2)

Antimicrobial agents’ development and marketing: Retrieved documents usually are not specific to AM, and some do not even mention them. Only for India, we identified a specific document for AM management, but

mainly targeting human drugs. Most of the documents covering drug development and marketing are

common to the human and veterinary sectors and are issued by authorities in charge of Public Health. We

identified texts specific to veterinary drugs in only Indonesia and Thailand. Prevailing legal and policy

instruments usually address three mains topics: (i) licensing and authorisation of drugs placed on the market;

(ii) requirements for drug manufacturers; (iii) requirements for distributing, selling and storing drugs.

Depending on the countries, requirements are more or less specific and detailed. Most countries require

licensing authorisation to release drugs, but few provide licensing criteria and precise description of

procedures. Policies retrieved from Nepal and Bangladesh underline the importance of science-based

assessment of drugs before market introduction. For drug manufacturing, obligation of licensing is

commonly addressed in the different records, but requirements are more or less strict depending on the

country. For instance, in four countries, Good Manufacturing Practices (GMP), as well as quality assurance

and control, are compulsory for drug manufacturers. Regarding drug storage and distribution, authorizations

are usually required by law, but requirements are poorly described. Official control measures carried out by

competent authorities are not commonly addressed. In Bhutan, the Medicines Rules and Regulation prescribe

pre-approval and routine GMP inspections to assess the conformance of pharmaceutical manufacturers to

GMP standards. In Bangladesh and India, the national policies provide for regular inspections of premises to

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control manufacture and sale of drugs but, to date, prevailing legal instruments are outdated to allow their

programming. In Thailand, numerous official controls are carried out on the manufacturing and distribution

of veterinary medicines at all levels [14].

Antimicrobial usage (AMU): Two main issues are commonly addressed: i) antibiotics in animal feed for growth promotion and medicated animal feed, ii) rational AMU in healthcare and veterinary settings. In

2015, Thailand banned the use of all antibiotics as growth promoter in food animals and authorized

medicated feed only with a prescription [12]. This restriction has been enforced in the country since 1999

(amendment B.E. 2542) with the total prohibition of medicated feed in aquaculture [15]. Thai competent

authorities conduct regular official controls on antibiotic use in farms and holdings [14]. Sri Lanka and

Maldives are prohibiting therapeutic antibiotics as growth promoters or in medicated feed [11]. Bangladesh

banned as well (bills or law) the use of antibiotics as a feed additive for livestock but without means to

inforce proper controls of operators’ activities. All further countries authorize the use of antibiotics in animal

feed for curative or preventive therapeutic use or growth promotion. For India, Nepal, and Bhutan, we found

national roadmaps aiming to ban non-therapeutic use of antibiotics in feed within the next two to four years;

however these countries are still in the process of updating their legal documents to achieve these goals. Few

countries have national policies or regulations on AMU in food animals. India and Thailand as significant

seafood exporters specified a list of antibiotics banned from use in aquaculture, in line with their trade

partners requirements [15]. Specific provisions on AMU have been specified in regulatory documents, e.g.

recommendation on the prudent use of antibiotics (Nepal), or restrictions on the use of antibiotics intended

for human treatments (Indonesia). Indonesia and Thailand have developed a code of practice for the control

of the use of veterinary drugs in compliance with the Codex recommendations (CAC/REP 38-1993) [13]. In

Bangladesh, Bhutan, India and Nepal, the public health sector have prepared national policies with specific

strategies and roadmaps for the containment of AMR, targeting human and animal health with the

implementation of inter-sectoral committee and tasks force. These national policies recommend the

responsible use of antibiotics, the ban of over-the-counter (OTC) sales of antibiotics, the formulation of

current regulatory documents, good pharmacists practices (GPP), the development of standard treatment

guidelines (STGs) and promote education campaigns for sellers and end-users of antibiotics. These

recommendations are in line with OIE standards, but no legal documents were yet retrieved from the

literature search showing effective implementation.

Antimicrobial surveillance and monitoring in food animal production: Thailand seems to be the most advanced country with regards to surveillance strategies and implementation of AMU and AMR monitoring.

The Department of Livestock Development (DLD) constituted a multidisciplinary committee on AMR

containment with a specific working group on surveillance. In 2016 the DLD developed National Veterinary

AMR surveillance in line with Decision 2013/652/EU although its legal framework is yet to be established.

The objective of surveillance is to detect resistant bacteria and resistance genes in the food chain from

poultry and pigs with a focus on Salmonella spp., E. coli, Campylobacter jejuni as recommended by OIE. The policy to approve surveillance of AMU is planned but yet to be developed. All these actions are in line

with the Thailand Antimicrobial Resistance Containment and Prevention Program [16]. Bangladesh issued in

2011 a national strategy that provides a framework for interventions to slow the emergence and spread of

AMR for the next 10 years (implementation before 2020). National AMR surveillance for the veterinary and

fisheries sector in line with OIE standards is to start end of 2016. The monitoring of AMU at the animal

healthcare center is planned to start during 2017-2020. Alongside, a roadmap was developed to set-up

surveillance of antibiotic use and AMR in human health. In India, veterinary surveillance of AMR is not in

place yet. In human health there is no national surveillance of AMR and AMU; although surveillance is

conducted independently in some large and/or private hospitals. Official documents from Bhutan’s Drug

Regulatory Authority provided rules and regulations regarding medicines targeting human and animal health

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but no specifics was found with respect to AMR in food animals. In the Bhutan Medicines Rules and

Regulation of 2012, no reference was made to AMR surveillance, but a monitoring system for adverse

reaction(s) of the drug use is described. Anyhow we found drafts of very recent policies documents which

are describing short-term plans to develop One Health-related AMR surveillance. Laboratory-based AMR

surveillance was set up in Nepal, including several public health facilities. Since 2011 the system has

included veterinary laboratories with samples from the poultry sector [11] but no surveillance data/records

were reported.

Policy-related best practices and global challenges for their implementation in food animal sector in

developing countries

While the pharmaceutical industry is to ensure the quality of antibiotics used in livestock, countries need

strong national regulatory framework to enforce compliance with good manufacturing practices and to

regulate licensing and sales. Other best practices should be science-based through risk assessment strategies

that focus on each antimicrobial agent. Policies must embrace the conditions of safe disposal of unused or

out-of-date antimicrobials. Finally, the policy and legislation should allow improved monitoring of drug

quality to curb the production of counterfeit and substandard antibiotics: there is indeed a need for an ad hoc legislation for the control (inspection) at many levels of the drug marketing chain - but this control should

not only target the farmers [17,18]. Policies should drive the development of surveillance on the use of

antimicrobial for terrestrial and aquatic animal health (and plants), on AMR in zoonotic agents and

commensal bacteria in food animals. Policy should encourage the development and use of standardised

diagnostic tools, alternatives to antibiotics and research for new anibiotics. Educational efforts for providers

(e.g. the veterinarians) and farmers must be continuous, developing appropriate materials and effective

communications strategies [19]. A participative approach that associates farmers in surveillance and

monitoring systems, especially of the AMU is crucial [20].

Recommendations to improve the design/implementation of best practice policies

Surveillance of AMR and antibiotic usage in animals are complementary and fundamental to monitor the

effectiveness of national AMR prevention and containment programs [21,22]. AMR surveillance in the

veterinary sector remains a challenge as veterinary services try to stretch their resources and capacities

beyond the ongoing surveillance on transboundary animal diseases to include AMR surveillance which

requires an active form of surveillance. Therefore, AMR surveillance needs to be teased out for countries to

understand what really needs to be done. There are various approaches to surveillance, namely: AMR in the

clinical context, related to non-therapeutic usage, residues, AMU for clinical cases and non-therapeutic

AMU. Understanding what each approach entails will allow the countries to prioritize and eventually help

shape policies.

Constant surveillance on AMU in food animals should be promoted, and especially in countries where the

ban of AM as growth promoter could drive producers to increase prophylactic use of AM. Following the

Global Action Plan on AMR, there is now an international consensus to ban antibiotics as growth promoters

in the absence of risk analysis [23]. Countries where legislation is still not in place to ban AM additives in

feed will face market limitations for products with promoters due to consumer pressure and export

restrictions. Integrating surveillance of AMR and AMU in both sectors remains a technical challenge due to

insufficient implementation of existing standards for surveillance [24]. WHO, OIE and FAO are

collaborating to address this issue.

Risk analysis, as recommended by the Codex Alimentarius and OIE guidelines [21,25,26], is an essential tool to evaluate the risk of AMR transmission on human health from animal food and feed, to identify specific

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risk mitigation strategies, and to communicate about the complexity of this risk and the actions to be taken.

Anyhow, risk analyses are mainly implemented to assess the risk of introducing new veterinary drugs on

national markets. Critical data about risk factors for the emergence and transmission of resistance, and

pathways (foods, environments, contacts) of transmission (of resistant pathogens or resistances genomes) are

still fragmented. WHO, OIE and FAO have an important role to play in providing more applied example of

risk analysis studies assessing potential impact of AMR emergence and transmission on animal, human and

environmental health, including technical support to deal with risk management options, stakeholders’

communications and risk perceptions of end-users.

Many knowledge gaps regarding the use and impact of antimicrobial agents in agriculture are identified and

listed by Thanner et al. (2016). There is a need to develop a global approach/policy linking various private

sectors, government, veterinarians and farmers’ representatives, and researchers to address the knowledge

gaps. Above all, an integrated policy is required and could be operationalized under the One Health

umbrella. As resistant organisms exist in humans, animals, food, and the environment - and the main driver

of this resistance is antimicrobial usage - a “One Health” conceptual framework for surveillance and control

can be promoted [27].

Conclusion

The region lags behind when it comes to introducing key policies to combat AMR including surveillance of

AMR and AMU, training of professionals and farmers, or the implementation of independent national drug

regulatory authorities. Notably given the political and economic context, many countries have not been able

to enforce policies that have been in place including bans on e.g. OTC and growth promoters. Many reasons may explain the current situation including low awareness and immediate competing priorities; and a limited

understanding of the relationship between AMU and AMR in animals, humans and the environment.

Addressing these issues all together will lay a solid ground for policy and its enforcement. resistance

surveillance and monitoring, governmental bodies should propose a stronger political action to change

antibiotic usage by better informing the citizens and using a proactive and transparent approach to promoting

prudent use of antimicrobials in food-producing animals [28].

Combating AMR is complex for which interventions in one sector will not be effective to addressing the

problem as a whole. Efforts are required for concerted multi-sectoral measures through strong political

leadership and governance. The tripartite partnership between FAO, OIE and WHO, can strengthen its role

in the region by proposing a corpus rules and legislation to support the countries and their national policy.

This corpus of best practices should be rooted in a sound evidence base and sufficiently flexible to

accommodate different contexts [29].

Contributors and sources: SV conceived the article. FLG wrote the first draft. CC, FLG, FR conducted the

systematic literature review. All the authors contributed to the article. FLG is guarantor.

Competing interests: This work was commissioned by the WHO Regional Office of South-East Asia using

the UK Government’s Fleming Fund. The authors alone are responsible for the views expressed in this

article, which does not necessarily represent the views, decisions, or policies of the institutions with which

the authors are affiliated.

This an open access article distributed under the terms of the Creative Commons Attribution-Noncommercial

IGO License (https//creativecommons.org/licenses/by-nc/3.0/igo/), which permits use, distribution, and

reproduction for non-commercial purposes in any medium, provided the original work is properly cited. In

any reproduction of this article there should not be any suggestion that WHO or this article endorse sny

specific organisation or products. The use of the WHO logo is not permitted. This notice should be preserved

along with the article´s original URL.

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KEY MESSAGES

• Key policies are missing in the region including ban on OTCs antibiotics and use of

antibiotics as growth promoters, setting up veterinary surveillance of AMR and AMU,

raising awareness among professionals and farmers, or strengthening the national drug

regulatory authorities in the animal health sector.

• Key policies such as ban on OTCs antibiotics and use of antibiotics as growth promoters

have been introduced in many countries. Their enforcements are recognized as major

challenges and country-dependent. Further evidence is needed to understand their barriers

and propose viable policy-driven solutions. WHO, OIE and FAO are keys actors to develop

contextual best practices in support to national policies development

•

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Box 1: Codex texts on foodborne antimicrobial resistance related best practices for AMR containment

in food animal sectors – Codex Alimentarius Commission [21]

• Guidelines for risk analysis of foodborne antimicrobial resistance (CAC/GL 77-2011,

Adopted 2011)

These guidelines aim to (i) “provide science-based guidance on processes and methodology for

risk analysis and its application to foodborne AMR related to non-human use of antimicrobial

agents”, (ii) “assess the risk to human health associated with the presence in food and animal

feed, including aquaculture, and the transmission through food and animal feed, of AMR

microorganisms and determinants, to provide advice on appropriate risk management activities

to reduce such risk”, (iii) “address the risk associated with different sectors of antimicrobial

agent use such as veterinary applications, plant protection or food processing.”

• Code of practice to minimize and contain antimicrobial resistance (CAC /RCP 61-

2005, Adopted 2005)

This Code provide recommendations to regulatory authorities and operators involved in the

authorisation, manufacture, sale and supply, prescription, and use of antimicrobials in food-

producing people, in order to prevent or reduce the selection of antimicrobial resistant

microorganisms in humans and animals.

These two texts , together with specific standards of importance to animal production, have

supported the development of the Global Action Plan on Antimicrobial Resistance (adopted in

May 2015), developed by WHO in collaboration with FAO and OIE.

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Box 2: OIE standards and guidelines related to antimicrobial agents and veterinary public health

[25,30]

Terrestrial Animal Health Code

Chapter 6.7. Harmonisation of national antimicrobial resistance surveillance

and monitoring programmes

Revision adopted in 2012

Chapter 6.8. Monitoring of the quantities and usage patterns of antimicrobial

agents used in food producing animals


Chapter 6.9. Responsible and prudent use of antimicrobial agents in veterinary medicine


Chapter 6.10. Risk analysis for antimicrobial resistance arising from the use of

antimicrobials in animals


Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

Chapter 3.1. Laboratory methodologies for bacterial antimicrobial

susceptibility testing

Current version adopted in May

2012

Aquatic Animal Health Code

Chapter 6.2. Principles for responsible and prudent use of antimicrobial agents

in aquatic animals

Adopted in 2011

Chapter 6.3. Monitoring of the quantities and usage patterns of antimicrobial

agents used in aquatic animals

Adopted in 2012

Chapter 6.4. Development and harmonisation of national antimicrobial

resistance surveillance and monitoring programmes for aquatic

animals

Adopted in 2012

Chapter 6.5. Risk analysis for antimicrobial resistance arising from the use of

antimicrobial agents in aquatic animals

Adopted in 2015

List of antimicrobial agents of veterinary importance

OIE List of antimicrobial agents of veterinary importance Revision adopted in 2015

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12

Table 1: List of official documents addressing antibiotics (excepting antimicrobial residue surveillance

and control) in the food animal production system from SEAR (Bangladesh, Bhutan, DPRK, India,

Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste) retrieved from the

literature review between 2010 and 2016.

L: Legislations; P: Policies; D/M: Development and marketing; U: Usage; M: Monitoring

Country Title Year Type D/M U M

Bangladesh

National Drug Policy 2005 P X - -

Fish feed and animal feed act 2010 L - X -

National Livestock Development Policy. 2007 P - X -

National strategy for antimicrobial resistance containment (ARC) 2011 P - X X

Road map of National Action Plan for ARC - P - X X

The drug (control) ordinance 1982 L X - -

Bhutan

Medicines Rules and Regulation 2012 L X X -

National action plan on anti-microbial resistance (Draft) 2015 P - X X

National antimicrobial policy (Draft) 2015 P - X X

India

Advisory on use of antibiotics in food producing animals 2014 P - X -

Drugs and Cosmetics act 1940 L X - -

National Livestock Policy 2013 P - X -

National policy for containment of antimicrobial resistance 2011 P X X X

Indonesia

Law No 18 on Husbandry and Animal Health 2009 L - X -

Manual for Prime Method of animal drugs manufacturing 1999 P X - -

Regulation of the Head of the Agency of Drug and Food Control n°27 2013 L X - -

Regulation of the Head of the Agency of Drug and Food Control n°28 2013 L X X -

Regulation of the Minister of Marine Affairs and Fishery on fish

medication 2012 L X - -

Terms and procedures for the issuance of Animal Medicine Business

Permit 2009 L X - -

Myanmar Fisheries law Directive 9.96 on general product standard 1996 L - X -

Nepal

Drug act 1978 L X - -

Drug registration rules 1981 L X - -

National drug policy 1995 P X X -

Sri Lanka Animal Diseases Act N°59 1992 L X - -

Thailand Code of practice for control of the use of veterinary drugs 2009 L - X -

Drug ACT B.E.2510 (A.C. 1967) and its amendment 2001 L X - -

Timor-Leste No official document

Korea DPR No official document

Maldives No official document

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Confidential: For Review Only13

Table 2: Summary of the information collected for the seven countries of the review, highlighting the main information and the gaps in policy

legislation

Topics Main components identified / planned Gaps identified

AM development

and marketing

Drugs commercialization: mandatory registration and authorisation,

administrative and quality requirements for authorization, authorization

cancellation/suspension conditions, active list for illegal substances.

Drug production and manufacture: compulsory registration for companies,

mandatory implementation of GMP and quality assurance and control, mandatory

compliance with quality requirements

Drug distribution, sale and storage: mandatory authorization for business

operators, mandatory compliance with quality and ethical requirements, active list

of medicines to be dispensed on the prescriptions of a registered medical

practitioner, antibiotics sale monitoring, quality assessment and licensing of

veterinary drugs, specific requirement for drugs importation/exportation,

assessment of the veterinary drugs quality before being placed on the market.

1. Antibiotics management poorly addressed as a specific

issue.

2. Legislation outdated regarding the emerging issue of

AMR.

3. Inadequacy between policy interventions and available

legal instruments.

4. Drugs management mainly addressed in the human sector.

AMU Appropriate and prudent use of antibiotics: detailed strategic plan for the

implementation of GMP, standard treatment guidelines, promotion of AST before

prescription, licensing of veterinary pharmacists, education, and awareness of

users.

Code of practices for control of the use of veterinary drugs: planned in 2

countries, in compliance with Codex

Legal framework on veterinary medicines and medicated feed: prohibition of

the use of antibiotics in feed as growth promoter (effective in one country),

control enforcement for irrational and non-therapeutic/sub-therapeutic use,

improvement of labelling and traceability, ban of certain antibiotics critical to

human health (especially in seafood production)

1. Existing of comprehensive and sound policies but no

corresponding legal instruments for their implementation.

2. Policy interventions mainly focused on good practices;

users and prescribers' awareness, diseases prevention, and

spread, while research and development (new

antimicrobials, vaccines, and diagnostic tools) are poorly

addressed.

3. Disproportionate national policy objectives regarding the

local socio-economic context.

AMU and AMR

monitoring

AMU monitoring: monitoring use and prescribing patterns, assessment of non-

therapeutic use in veterinary sector, monitoring and evaluation of the impact of

promotion on consumption, data dissemination to users and prescribers,

AMR surveillance: appropriate laboratory capabilities and networking,

development of surveillance protocol, harmonized AST results reporting system,

prioritization of bacteria to be monitored, dissemination of data to stakeholders,

development of a national strains repository

1. Topic poorly addressed in the countries while recognised

as a cornerstone to provide necessary data to fight

efficiently on AMR.

2. No legal framework to implement the monitoring

objectives when existing.

3. Achievable objectives if an appropriate budget is allocated

for monitoring actions.

AMR: antimicrobial resistance; AMU: antimicrobial usage; AST: antimicrobial susceptibility testing; GPP: good pharmacists’ practices; GMP: good manufacturing practice

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Figure 1: PRISMA flow chart diagram of studies selection process to include in the systematic review

234x297mm (150 x 150 DPI)

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confidential: for review only · 2017-09-07 · antimicrobial usage (amu): two main issues are...

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